510(k) K981698
K981698 is an FDA 510(k) premarket notification submitted by Chiron Corp. for the device "ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)". The FDA issued a decision of Substantially Equivalent on July 10, 1998. The device falls under product code MOI (System, Test, Immunological, Antigen, Tumor), a Class II device regulated under 21 CFR 866.6010. Chiron Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 1998
- Date Received
- May 14, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Immunological, Antigen, Tumor
- Device Class
- Class II
- Regulation Number
- 866.6010
- Review Panel
- IM
- Submission Type